Amendment of Class E Airspace, Ithaca, NY, 65278-65279 [2016-22741]
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65278
Federal Register / Vol. 81, No. 184 / Thursday, September 22, 2016 / Rules and Regulations
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA–2016–8816; Airspace
Docket No. 16–AEA–5]
Amendment of Class E Airspace,
Ithaca, NY
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule.
AGENCY:
This action amends Class E
airspace Designated as an Extension at
Ithaca Tompkins Regional Airport,
Ithaca, NY, by updating the geographic
coordinates of the Ithaca VHF
omnidirectional range/distance
measuring equipment, (VOR/DME), and
the airport, as well as changing the
airport name. This is an administrative
change and does not affect the
boundaries or operating requirements of
the airspace.
DATES: Effective 0901 UTC, November
10, 2016. The Director of the Federal
Register approves this incorporation by
reference action under Title 1, Code of
Federal Regulations, part 51, subject to
the annual revision of FAA Order
7400.11 and publication of conforming
amendments.
ADDRESSES: FAA Order 7400.11A,
Airspace Designations and Reporting
Points, and subsequent amendments can
be viewed online at https://www.faa.gov/
air_traffic/publications/. For further
information, you can contact the
Airspace Policy Group, Federal Aviation
Administration, 800 Independence
Avenue SW., Washington, DC 20591;
telephone: 202–267–8783. The Order is
also available for inspection at the
National Archives and Records
Administration (NARA). For
information on the availability of FAA
Order 7400.11A at NARA, call 202–741–
6030, or go to https://www.archives.gov/
federal_register/code_of_federalregulations/ibr_locations.html.
FAA Order 7400.11, Airspace
Designations and Reporting Points, is
published yearly and effective on
September 15.
FOR FURTHER INFORMATION CONTACT: John
Fornito, Operations Support Group,
Eastern Service Center, Federal Aviation
Administration, P.O. Box 20636,
Atlanta, Georgia 30320; telephone (404)
305–6364.
SUPPLEMENTARY INFORMATION:
ehiers on DSK5VPTVN1PROD with RULES
SUMMARY:
Authority for This Rulemaking
The FAA’s authority to issue rules
regarding aviation safety is found in
VerDate Sep<11>2014
15:00 Sep 21, 2016
Jkt 238001
Title 49 of the United States Code.
Subtitle I, Section 106 describes the
authority of the FAA Administrator.
Subtitle VII, Aviation Programs,
describes in more detail the scope of the
agency’s authority. This rulemaking is
promulgated under the authority
described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that
section, the FAA is charged with
prescribing regulations to assign the use
of airspace necessary to ensure the
safety of aircraft and the efficient use of
airspace. This regulation is within the
scope of that authority as it amends
Class E airspace at Ithaca Tompkins
Regional Airport, Ithaca, NY.
History
In a review of the airspace for Ithaca
Tompkins Regional Airport (formerly
Tompkins County Airport), Ithaca, NY,
the FAA found the airport name and
geographic coordinates for the airport
and the Ithaca VOR/DME, as published
in FAA Order 7400.11A, Airspace
Designations and Reporting Points, do
not match the FAA’s charting
information for Class E Airspace
Designated as an Extension to a Class D
Surface Area.
Class E airspace designations are
published in paragraph 6004 of FAA
Order 7400.11A dated August 3, 2016,
and effective September 15, 2016, which
is incorporated by reference in 14 CFR
part 71.1. The Class E airspace
designations listed in this document
will be published subsequently in the
Order.
Availability and Summary of
Documents for Incorporation by
Reference
This document amends FAA Order
7400.11A, Airspace Designations and
Reporting Points, dated August 3, 2016,
and effective September 15, 2016. FAA
Order 7400.11A is publicly available as
listed in the ADDRESSES section of this
document. FAA Order 7400.11A lists
Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting
points.
The Rule
This action amends Title 14 Code of
Federal Regulations (14 CFR) Part 71 by
amending Class E airspace designated as
an extension at Ithaca Tompkins
Regional Airport, Ithaca, NY. A minor
adjustment to the geographic
coordinates of the airport and the Ithaca
VOR/DME is made to be in concert with
the FAA’s aeronautical database, as well
as a name change from Tompkins
County Airport to Ithaca Tompkins
Regional Airport.
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
This is an administrative change and
does not affect the boundaries, or
operating requirements of the airspace,
therefore, notice and public procedure
under 5 U.S.C. 553(b) are unnecessary.
Regulatory Notices and Analyses
The FAA has determined that this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current. It, therefore: (1) Is not a
‘‘significant regulatory action’’ under
Executive Order 12866; (2) is not a
‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
Regulatory Evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that will only affect air
traffic procedures and air navigation, it
is certified that this proposed rule,
when promulgated, will not have a
significant economic impact on a
substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
Environmental Review
The FAA has determined that this
action qualifies for categorical exclusion
under the National Environmental
Policy Act in accordance with FAA
Order 1050.1F, ‘‘Environmental
Impacts: Policies and Procedures,’’
paragraph 5–6.5a. This airspace action
is not expected to cause any potentially
significant environmental impacts, and
no extraordinary circumstances exist
that warrant preparation of an
environmental assessment.
Lists of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for part 71
continues to read as follows:
■
Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting
Points, dated August 3, 2016, effective
■
E:\FR\FM\22SER1.SGM
22SER1
Federal Register / Vol. 81, No. 184 / Thursday, September 22, 2016 / Rules and Regulations
September 15, 2016, is amended as
follows:
Paragraph 6004 Class E Airspace
Designated as an Extension to a Class D
Surface Area.
*
*
*
*
*
AEA NY E4 Ithaca, NY [Amended]
Ithaca Tompkins Regional Airport, Ithaca,
NY
(Lat. 42°29′29″ N., long. 76°27′31″ W.)
Ithaca VOR/DME
(Lat. 42°29′42″ N., long. 76°27′35″ W.)
That airspace extending upward from the
surface from the 4-mile radius of the Ithaca
Tompkins Regional Airport to the 5.7-mile
radius of the airport; clockwise from the 329°
bearing to the 081° bearing from the airport;
that airspace from the 4-mile radius of Ithaca
Tompkins Regional Airport to the 8.7-mile
radius of the airport extending clockwise
from the 081° bearing to the 137° from the
airport; that airspace from the 4-mile radius
of Ithaca Tompkins Regional Airport; to the
6.6-mile radius of the airport, extending
clockwise from the 137° bearing to the 170°
bearing from the airport; that airspace from
the 4-mile radius to the 5.7-mile radius of the
Ithaca Tompkins Regional Airport, extending
clockwise from the 170° bearing to the 196°
bearing from the airport; and that airspace
within 2.7 miles each side of the Ithaca VOR/
DME 305° radial extending from the 4-mile
radius of Ithaca Tompkins Regional Airport
to 7.4 miles northwest of the Ithaca VOR/
DME. This Class E airspace area is effective
during specific dates and times established in
advance by a Notice to Airmen. The effective
date and time will thereafter be published
continuously in the Airport/Facility
Directory.
Issued in College Park, Georgia, on
September 7, 2016.
Joey L. Medders,
Acting Manager, Operations Support Group,
Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2016–22741 Filed 9–21–16; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 886
[Docket No. FDA–2016–N–2656]
Medical Devices; Ophthalmic Devices;
Classification of Strabismus Detection
Device
ehiers on DSK5VPTVN1PROD with RULES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA) is classifying the
strabismus detection device into class II
(special controls). The special controls
SUMMARY:
VerDate Sep<11>2014
15:00 Sep 21, 2016
Jkt 238001
that will apply to the device are
identified in this order and will be part
of the codified language for the
strabismus detection device’s
classification. The Agency is classifying
the device into class II (special controls)
in order to provide a reasonable
assurance of safety and effectiveness of
the device.
DATES: This order is effective September
22, 2016. The classification was
applicable on June 8, 2016.
FOR FURTHER INFORMATION CONTACT:
Elvin Ng, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2431, Silver Spring,
MD 20993–0002, 240–402–4662,
elvin.ng@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C.
360c(f)(1)), devices that were not in
commercial distribution before May 28,
1976 (the date of enactment of the
Medical Device Amendments of 1976),
generally referred to as postamendments
devices, are classified automatically by
statute into class III without any FDA
rulemaking process. These devices
remain in class III and require
premarket approval, unless and until
the device is classified or reclassified
into class I or II, or FDA issues an order
finding the device to be substantially
equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate
device that does not require premarket
approval. The Agency determines
whether new devices are substantially
equivalent to predicate devices by
means of premarket notification
procedures in section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part
807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as
amended by section 607 of the Food and
Drug Administration Safety and
Innovation Act (Pub. L. 112–144),
provides two procedures by which a
person may request FDA to classify a
device under the criteria set forth in
section 513(a)(1). Under the first
procedure, the person submits a
premarket notification under section
510(k) of the FD&C Act for a device that
has not previously been classified and,
within 30 days of receiving an order
classifying the device into class III
under section 513(f)(1) of the FD&C Act,
the person requests a classification
under section 513(f)(2). Under the
second procedure, rather than first
submitting a premarket notification
under section 510(k) of the FD&C Act
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
65279
and then a request for classification
under the first procedure, the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence and requests a classification
under section 513(f)(2) of the FD&C Act.
If the person submits a request to
classify the device under this second
procedure, FDA may decline to
undertake the classification request if
FDA identifies a legally marketed device
that could provide a reasonable basis for
review of substantial equivalence with
the device or if FDA determines that the
device submitted is not of ‘‘lowmoderate risk’’ or that general controls
would be inadequate to control the risks
and special controls to mitigate the risks
cannot be developed.
In response to a request to classify a
device under either procedure provided
by section 513(f)(2) of the FD&C Act,
FDA shall classify the device by written
order within 120 days. This
classification will be the initial
classification of the device.
On December 11, 2013, RebiScan,
Inc., submitted a request for
classification of the Pediatric Vision
Scanner under section 513(f)(2) of the
FD&C Act.
In accordance with section 513(f)(2) of
the FD&C Act, FDA reviewed the
request in order to classify the device
under the criteria for classification set
forth in section 513(a)(1). FDA classifies
devices into class II if general controls
by themselves are insufficient to
provide reasonable assurance of safety
and effectiveness, but there is sufficient
information to establish special controls
to provide reasonable assurance of the
safety and effectiveness of the device for
its intended use. After review of the
information submitted in the request,
FDA determined that the device can be
classified into class II with the
establishment of special controls. FDA
believes these special controls, in
addition to general controls, will
provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, on June 8, 2016, FDA
issued an order to the requestor
classifying the device into class II. FDA
is codifying the classification of the
device by adding 21 CFR 886.1342.
Following the effective date of this
final classification order, any firm
submitting a premarket notification
(510(k)) for a strabismus detection
device will need to comply with the
special controls named in this final
order.
The device is assigned the generic
name strabismus detection device, and
it is identified as a prescription device
designed to simultaneously illuminate
E:\FR\FM\22SER1.SGM
22SER1
Agencies
[Federal Register Volume 81, Number 184 (Thursday, September 22, 2016)]
[Rules and Regulations]
[Pages 65278-65279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22741]
[[Page 65278]]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
[Docket No. FAA-2016-8816; Airspace Docket No. 16-AEA-5]
Amendment of Class E Airspace, Ithaca, NY
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This action amends Class E airspace Designated as an Extension
at Ithaca Tompkins Regional Airport, Ithaca, NY, by updating the
geographic coordinates of the Ithaca VHF omnidirectional range/distance
measuring equipment, (VOR/DME), and the airport, as well as changing
the airport name. This is an administrative change and does not affect
the boundaries or operating requirements of the airspace.
DATES: Effective 0901 UTC, November 10, 2016. The Director of the
Federal Register approves this incorporation by reference action under
Title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.
ADDRESSES: FAA Order 7400.11A, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: 202-267-8783.
The Order is also available for inspection at the National Archives and
Records Administration (NARA). For information on the availability of
FAA Order 7400.11A at NARA, call 202-741-6030, or go to https://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.
FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
SUPPLEMENTARY INFORMATION:
Authority for This Rulemaking
The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends Class E airspace at Ithaca Tompkins Regional Airport,
Ithaca, NY.
History
In a review of the airspace for Ithaca Tompkins Regional Airport
(formerly Tompkins County Airport), Ithaca, NY, the FAA found the
airport name and geographic coordinates for the airport and the Ithaca
VOR/DME, as published in FAA Order 7400.11A, Airspace Designations and
Reporting Points, do not match the FAA's charting information for Class
E Airspace Designated as an Extension to a Class D Surface Area.
Class E airspace designations are published in paragraph 6004 of
FAA Order 7400.11A dated August 3, 2016, and effective September 15,
2016, which is incorporated by reference in 14 CFR part 71.1. The Class
E airspace designations listed in this document will be published
subsequently in the Order.
Availability and Summary of Documents for Incorporation by Reference
This document amends FAA Order 7400.11A, Airspace Designations and
Reporting Points, dated August 3, 2016, and effective September 15,
2016. FAA Order 7400.11A is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11A lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.
The Rule
This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by amending Class E airspace designated as an extension at
Ithaca Tompkins Regional Airport, Ithaca, NY. A minor adjustment to the
geographic coordinates of the airport and the Ithaca VOR/DME is made to
be in concert with the FAA's aeronautical database, as well as a name
change from Tompkins County Airport to Ithaca Tompkins Regional
Airport.
This is an administrative change and does not affect the
boundaries, or operating requirements of the airspace, therefore,
notice and public procedure under 5 U.S.C. 553(b) are unnecessary.
Regulatory Notices and Analyses
The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
Environmental Review
The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.
Lists of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference, Navigation (air).
Adoption of the Amendment
In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:
PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS
0
1. The authority citation for part 71 continues to read as follows:
Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Sec. 71.1 [Amended]
0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11A,
Airspace Designations and Reporting Points, dated August 3, 2016,
effective
[[Page 65279]]
September 15, 2016, is amended as follows:
Paragraph 6004 Class E Airspace Designated as an Extension to a
Class D Surface Area.
* * * * *
AEA NY E4 Ithaca, NY [Amended]
Ithaca Tompkins Regional Airport, Ithaca, NY
(Lat. 42[deg]29'29'' N., long. 76[deg]27'31'' W.)
Ithaca VOR/DME
(Lat. 42[deg]29'42'' N., long. 76[deg]27'35'' W.)
That airspace extending upward from the surface from the 4-mile
radius of the Ithaca Tompkins Regional Airport to the 5.7-mile
radius of the airport; clockwise from the 329[deg] bearing to the
081[deg] bearing from the airport; that airspace from the 4-mile
radius of Ithaca Tompkins Regional Airport to the 8.7-mile radius of
the airport extending clockwise from the 081[deg] bearing to the
137[deg] from the airport; that airspace from the 4-mile radius of
Ithaca Tompkins Regional Airport; to the 6.6-mile radius of the
airport, extending clockwise from the 137[deg] bearing to the
170[deg] bearing from the airport; that airspace from the 4-mile
radius to the 5.7-mile radius of the Ithaca Tompkins Regional
Airport, extending clockwise from the 170[deg] bearing to the
196[deg] bearing from the airport; and that airspace within 2.7
miles each side of the Ithaca VOR/DME 305[deg] radial extending from
the 4-mile radius of Ithaca Tompkins Regional Airport to 7.4 miles
northwest of the Ithaca VOR/DME. This Class E airspace area is
effective during specific dates and times established in advance by
a Notice to Airmen. The effective date and time will thereafter be
published continuously in the Airport/Facility Directory.
Issued in College Park, Georgia, on September 7, 2016.
Joey L. Medders,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2016-22741 Filed 9-21-16; 8:45 am]
BILLING CODE 4910-13-P